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Unapproved Drugs

All articles tagged with #unapproved drugs

FDA may expand access to unapproved peptides, but safety remains unsettled
health16 days ago

FDA may expand access to unapproved peptides, but safety remains unsettled

A FDA advisory panel voted to increase access to six unapproved peptides via compounding pharmacies with prescriptions, potentially changing peptide regulation. Experts caution that being more accessible does not mean these peptides are proven safe or effective—many remain untested and unregulated—though compounding could improve purity. The panel's recommendation is not final, and formal rulemaking is required; consumers should weigh potential benefits against significant safety uncertainties.

FDA Recalls 7 Brands of Amazon Eye Drops for Unauthorized Distribution
health2 years ago

FDA Recalls 7 Brands of Amazon Eye Drops for Unauthorized Distribution

The US Food and Drug Administration (FDA) has warned Amazon for selling seven brands of eye drops that are considered "unapproved new drugs." The FDA stated that these products can be classified as "new drugs" being distributed without FDA approval, which violates federal regulations. Amazon has started removing the products from its online marketplace. This warning follows previous FDA alerts about contaminated eye drops, which can lead to eye infections and vision loss. The FDA has urged caution regarding the use of certain eye drop products due to contamination from bacteria or fungus.

FDA Recalls 7 Brands of Amazon Eye Drops for Unauthorized Distribution
health2 years ago

FDA Recalls 7 Brands of Amazon Eye Drops for Unauthorized Distribution

The US Food and Drug Administration (FDA) has warned Amazon for selling seven brands of eye drops that are considered "unapproved new drugs." The FDA stated that these products can be classified as "new drugs" being distributed without FDA approval, which violates federal regulations. Amazon has started removing the products from its online marketplace. This warning follows previous FDA alerts about contaminated eye drops, which can lead to eye infections and vision loss. The FDA has urged caution regarding the use of certain eye drop products due to contamination from bacteria or fungus.